Leica Surgical Microscopes (2016-01-25)

Starting date:

January 25, 2016

Posting date:

February 26, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-57280

• Reason
• Affected products

Affected Products

A. LEICA M525 OH4 SURGICAL MICROSCOPE WITH 400W ILLUMINATION

B. LEICA M720 OH5 SURGICAL MICROSCOPE WITH 400W ILLUMINATION

Reason

Leica Microsystems Schweiz informed the importer that an electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could lead to an unforeseen behavior. An electronic component in one of the two illumination units can potentially overheat, resulting in modest smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.The observed malfunction can only occur on devices that include a 400W power supply, type HBX 400.

Affected products